An interventional study of Liberal RBC Transfusion Strategy and Restrictive RBC Transfusion Strategy in Subarachnoid Hemorrhage, Aneurysmal, sponsored by Ottawa Hospital Research Institute. Completed at 23 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
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Among 27 studies in Subarachnoid Hemorrhage with a site in Canada — 4 open to participants now, 5 under way, none of them phase 3. Subarachnoid Hemorrhage · Canada.
Among the 27 studies in Subarachnoid Hemorrhage with a site in Canada, this one is the 2nd largest by enrollment of the 23 interventional ones that give a count, is the only one that started in 2018, is one of 6 with no phase, and was the 19th registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
Browse Subarachnoid Hemorrhage studies →4 of the 27 studies in Subarachnoid Hemorrhage with a site in Canada are open now. Recruiting first, the newest first:
Columbia University · Sites in Canada, United States, Brazil and 2 more countries
Ages 18+
University of Alberta · Sites in Canada, United States
Ages 18–85
University of Alberta · Sites in Canada, United States
Ages 18–85
CHU de Quebec-Universite Laval · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 8 · Phase 3 6 · Phase 4 2
First in 2000; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 742 is above the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Median enrollment 73 across the 23 interventional studies, 393 across the 4 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
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11 of 27 have an industry lead sponsor. The 10 most frequent:
Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
Ottawa Hospital Research Institute has 2 studies filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Subarachnoid Hemorrhage with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.
We hypothesize that in adult patients suffering from aSAH and anemia, a liberal RBC transfusion strategy as compared to a restrictive RBC transfusion strategy decreases the combined rate of death and severe disability at 12 months (using the modified Rankin Scale)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin value of ≤100g/L
Other: Liberal RBC Transfusion Strategy
Hemoglobin value of ≤80g/L
Other: Restrictive RBC Transfusion Strategy
RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
Modified Rankin Scale (mRS)
The Modified Rankin Scale (mRS) is a functional outcome measure in stroke. The interview consists of five sections: Constant Care, Assistance to Attend to Bodily Needs/For Walking, Assistance to Look After Own Affairs, Usual Duties and Activities and Symptoms as a Result of Stroke. The scale is scored from 0 reporting no symptoms at all, to 5 reporting severe disability. Death is indicated by a score of 6.
Time frame: 12 months post
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) assesses the level of a patient's disability considering the amount of support needed to care for them.Items are scored on the basis of how much assistance is required for the individual to carry out activities of daily living. The FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from 1 to 7. The 2 subscales are then added to give a total FIM score between 18 and 126. The higher the score, the more independent the patient is in performing activities of daily living.
Time frame: 12 months post
EuroQOL Quality of Life Scale (EQ5D)
The EQ-5D measures generic health status. There are 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety/Depression which are answered by 5 Problem Levels: None, Slight, Moderate, Severe and Unable. The result is a 5 digit number, 11111 indicating no problem in any dimension to 55555 indicating unable to complete in all dimensions. Quality of life is also assessed on a visual analog scale reported from 0 being the worst imaginable health status to 100 as the best imaginable health status.
Time frame: 12 months post
Red Blood Cell Transfusions
The total number of red blood cell transfusions received.
Time frame: up to 21 days
Daily Hemoglobin
The lowest daily hemoglobin values.
Time frame: up to 21 days
Transfusion-related Complications
Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
Time frame: up to 28 days
Delayed Cerebral Ischemia and Vasospasm
The incidence and severity of delayed cerebral ischemia and vasospasm.
Time frame: up to 28 days
Cerebral Infarction
The incidence of cerebral infarctions.
Time frame: up to 28 days
Mechanical Ventilation
If required, the duration of mechanical ventilation.
Time frame: up to 21 days
Length of Stay
The length of ICU or hospital stay.
Time frame: 12 months post
Mortality
The number of deaths.
Time frame: 12 months post
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Jul 2024, 76 months.
Of 57 non-industry interventional studies with no phase under Subarachnoid Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 62. This study's 76 months is above that.
Counting every sponsor, half of 67 studies reached it within 32 months; a quarter within 20 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute →